Skin Fluorescent Imaging (SFI) System in Patients With Nevi

The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.

Study Overview

• Status: Unknown
• Conditions: Nevus; Dysplasia; Epithelial
• Intervention / Treatment: Diagnostic test: Skin Fluorescent Imaging

Detailed Description

The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: BRANDI DUNN; Phone Number: 2107714024; Email: brandi.dunn@orlucent.com
• Study Contact Backup: Name: Cathy Shachaf; Email: cshachaf@orlucent.com

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • Center For Dermatology Clinical Research, Inc
      • Contact: Anchal Dhawan
    • Northridge, California, United States, 91324
      • Not yet recruiting
      • Quest Dermatology Research
    • Vallejo, California, United States, 94590
      • Recruiting
      • Solano Dermatology Associates
      • Contact: Serena Mraz, MD
      • Principal Investigator: Serena Mraz, MD
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Not yet recruiting
      • University of Utah
      • Contact: Doug Grossman, MD
      • Principal Investigator: Douglas Grossman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects who present with suspicious nevus/nevi and who require a Standard of Care (SOC) biopsy of the atypical nevi will be able to participate in the study.

Description

Inclusion Criteria:

In order to be eligible to participate in this study a subject must meet all of the following criteria:

• Provide a signed and dated informed consent form
• Age ≥ 18 years old
• Subjects must present with suspicious atypical nevi scheduled for a biopsy*
• Nevi with at least 1 cm of skin surrounding the mole
• Nevi must be accessible to the SFI imaging device
• Excisional or a tangential excision with a dept of 1 to 2 mm biopsy will be performed for the mole tested within 21 days of testing.
• Nevi with clinically atypical features

Only 1 mole per eligible subject will be SFI tested in this study. *NOTE: a subset of patients (~10%) with benign nevi (by clinical observation) who wish to have nevi removed for cosmetic reasons will be enrolled as negative controls.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Subjects who are younger than 18 years old

• Lesions that are consistent with

  - Features of Keratosis and keratin plugs

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • Challenging anatomical location (e.g., body cervices)

• Subjects with nevi that fit the inclusion criteria but are:

  • Less than 1 cm from the eyes
  • On the palms of the hands or soles of the feet
  • Associated with scar tissue
  • Mucosal lesions
  • Ulcerated lesions / breached skin
  • Lesions with some clinical certainty of being melanomas (large, dark, etc.)
  • Any nevi with ink marking including tattoos, on or adjacent to the nevi
  • Lesions treated with local anesthesia such as lidocaine prior to enrollment
  • Lesions larger than 20 mm or too large to allow imaging
  • Subject is known to be pregnant
  • Subject who is mentally or physically unable to comply with all aspects of the study
  • Subject who is undergoing systemic cancer treatment within 6 months of SFI testing
  • Subject with hypersensitivity to any of the SFI reagents
  • Subjects with known sensitivity to fluorescent dyes
  • Any subject who has previously participated (testing to biopsy) in SFI 003

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nevi undergoing biopsy per SOC; Subjects with Nevi who will as part of their standard of care, will undergo biopsy.	Diagnostic test: Skin Fluorescent Imaging; Application of reagents, then imaging and scoring; Other Names: SFI 003 Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the performance of SFI	Establish the performance (sensitivity and specificity) for SFI in comparison to dysplasia.	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare SFI to clinical diagnosis.	Comparison of the SFI score ( 0 to 10) to the clinical diagnosis of the physician assessing and the pathologist	1 year
To establish the tolerability of SFI Testing by documenting minimal, transient events that occur with reagent application.	Adverse events will be collected to ensure overall safety of reagents and imaging	1 year

Collaborators and Investigators

• Sponsor: Orlucent, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (ACTUAL): April 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Nevus; Atypical Nevi; Mole; Skin Imaging
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus
• Other Study ID Numbers: SFI 003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No